ciNPT in Autologous DIEP Flap Breast Reconstruction

NANot yet recruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

March 31, 2026

Conditions
Breast CancerWound Dehiscence, Surgical
Interventions
DEVICE

ciNPT

Following closure of the abdominal donor site, the closed incision will be dressed with the ciNPT system \[V.A.C.ULTA™ Negative Pressure Wound Therapy System (KCI, USA)\] applied by the operating surgeon in a sterile fashion (Figure 2). The ciNPT device will be set at -125mmHg of continuous negative pressure for a period of 7 days or until patient discharge from hospital. Removal of the ciNPT dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied to the abdominal incision unless clinically indicated secondary to dehiscence.

OTHER

Conventional Tape Dressings

Following closure of the abdominal donor site, the closed abdominal incision will be dressed with 1-inch Micropore™ Surgical Tape (3M, USA) with an alcohol swab applied to the tape for additional adhesion, by the operating surgeon in a sterile fashion. This dressing will remain in-situ for up to 7 days or until patient discharge from hospital. Removal of the traditional tape dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied unless clinically indicated secondary to dehiscence.

PROCEDURE

DIEP Breast Reconstruction

All patients enrolled in the study will undergo DIEP breast reconstruction and have their abdominal incision sutured according to routine clinical practice. At the Hamilton sites, we will use 3-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 4-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 5-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure. At the London sites, we will use 2-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 3-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 4-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure.

All Listed Sponsors
collaborator

Western University

OTHER

lead

McMaster University

OTHER

NCT05907941 - ciNPT in Autologous DIEP Flap Breast Reconstruction | Biotech Hunter | Biotech Hunter